Minimally invasive device and method for tightening sagging skin by linear tensing and stimulation of collagen production, wherein the anesthesia, heat, and additional collagen induction or anti-inflammatory fluids can be applied with the same apparatus and in the same area

ABSTRACT

The invention provides an innovative low cost, efficient, short duration, and painless minimally invasive device and method for tightening sagging skin through linear tensing and stimulation of collagen production. More particularly still, the device and method not only allow applying heat directly in the dermis layer of the skin, but also allows for administering an anesthetic and optionally additional ant-inflammatory or collagen induction fluids through the same apparatus.

FIELD OF THE INVENTION

The present invention relates generally to the field of minimallyinvasive cosmetic procedures for improving the laxity of the skin and todelay the signs of aging in humans. More particularly, the inventionprovides an innovative low cost, efficient, short duration, and painlessminimally invasive device and method for tightening sagging skin throughlinear tensing and stimulation of collagen production. More particularlystill, the device and method not only allow applying heat directly inthe dermis layer of the skin, but also allows for administering ananesthetic and optionally additional anti-inflammatory or collageninduction fluids through the same apparatus.

BACKGROUND

A desire of a youthful appearance has become common in our society andhas resulted in an improvement in cosmetic procedures aiming to reversethe aging process. Throughout the latter part of the 20th Century,advances in medicine and nutrition, combined with an increasingawareness of individual healthcare, have enabled people to live longer,healthier, and in more productive way. As the population ages, morepeople are seeking ways to enhance their appearance for personal andprofessional reasons. Beauty and youth became significant determinantsof economic security, and in order to appear well groomed and confidentas well as to remain viable in the workplace, middle aged men and women,began seeing the growing specialty of cosmetic surgery as a solution tothe natural signs of aging.

As people age, their concerns about their appearance mainly focuses onthe face. Studies have indicated that while younger men and women weremostly concerned about the shape and appearance of their bodies, olderindividuals were worried about their faces. In particular, the oldergroups disliked wrinkles and drooping skin. Research also shows that 4out of 5 American women follow beauty industry trends and regularly usefragrance products, and according to the American Society of PlasticSurgeons (ASPS), almost 18 million people underwent surgical andminimally invasive cosmetic procedures in the United States in 2018.

The foregoing explains why the beauty industry has grown exponentiallyin the last decades to become today a global business that is worth morethan USD 500 billion, and while projections for growth vary, most agreeit will continue to advance at a 5%-to-7% compound-annual-growth-rate toreach or exceed $800 billion by 2025 in the world.

Therefore, there is a need in the art for a device and method thatprovides a minimally invasive cosmetic procedure for improving laxity ofthe skin and to delay the signs of aging in humans that addresseslimitations in available devices and procedures.

SUMMARY

A preferred embodiment in accordance with the principles of the presentinvention provides for a device and method that is minimally invasivedirected to cosmetic procedures for improving the laxity of the skin anddelaying the signs of aging in humans. In particular, the inventionprovides an innovative low cost, efficient, short duration, and painlessminimally invasive device and method for tightening sagging skin throughlinear tensing and stimulation of collagen production, wherein theapparatus not only allows applying heat directly in the dermis layer ofthe skin, but also allows administering an anesthetic and optionallyadditional treatment fluids through the same apparatus and in the samearea. In this manner many of the limitations of the existing devices andprocedures are overcome.

While those of skill in the art may have an understanding of causes andexisting treatments for improving laxity of the skin and delaying signsof aging, a brief description is next provided.

Intrinsic aging processes include loss of skin elasticity and collagen,along with fat atrophy. Extrinsic factors, such as solar radiation,damage the skin, with impacts on collagen and elastic fibers. Otherfactors that can contribute to an aged appearance to the face includegeneral poor health, an unhealthy diet, cigarette smoking, and alcohol.The main and often most perceived signs of aging include a linedforehead, drooping brows, loss of cheek roundedness, sagging neck lines,loss of chin definition, drooping of the nasal tissues, and wrinkling ofthe skin around the mouth.

In order to understand the aging process, it is important to bear inmind that skin is made of two main layers: the outer one is theepidermis, made mainly by keratinocytes, responsible for the formationof a barrier against environmental damages (e.g., pathogens, heat, UVradiation and water loss). The inner layer, the dermis, comprisesconnective tissue, made by structural components such as collagen(responsible for the skin firmness), elastic fibers (responsible of theskin elasticity) and extracellular matrix (structural component). Athird layer of subcutaneous tissues contains fat cells that provideinsulation to the body.

The formation of skin wrinkles and subsequent skin sagging is triggeredby a failure of the skin structures from a lack of collagen or to itschanges, like thinning and/or fractioning, caused by the stretching andrepeated extension of some areas of the skin, especially the face, onwhich the lack of elastin has an important role. Its decrease andsubsequent loss of elasticity, causes an increase of volume of the skinand issues such as the double chin. All these combined changes in thescaffolding of the skin cause the appearance of wrinkles, the shape andform of which depends on the nature of associated skin and musclecontraction. The consequences of this degenerative process lead toenhanced skin fragility and a decrease of the amount of nutrientsavailable to the epidermis. These consequences interfere with the normalskin repair process, therefore causing more noticeable wrinkling andsagging. In addition, by making facial expressions regularly, musclespermanently contract causing the skin to wrinkle due to loss of tissuesas described above. Moreover, the effects of gravity are alsoresponsible for the appearance of wrinkles and skin sagging. Thispromotes jowls and drooping eyelids.

Aging as such, is an irreversible occurrence that affects the skin dueto a decrease of structural substances included in the layers or inimperfect remodeling of the fibers (mainly collagen) and othermultifactorial issues that cause the formation of wrinkles. Regenerationof the lost tissues, including mainly collagen fibers and elastin, istherefore a critical target for wrinkle treatment and prevention.

In order to reduce sagging of skin and wrinkles, there are two maincategories for different types of lifting techniques: (A) Surgicallifts, and (B) non-surgical lifts.

Surgical lifts, such as eyelid surgery, face lifts, and forehead liftshave seen a more than 50% decrease over the last 18 years, whilenon-surgical facial rejuvenation procedures continue to experiencegrowth, with more than USD 6.8 billon spent on non-surgical skinrejuvenation in 2016 in the U.S. alone.

Non-surgical facial rejuvenation, although it has less dramatic resultsthan surgical options, has grown due to its advantages related to lessdowntime, lower costs, less risky, and shorter duration than surgicalprocedures.

Today, there are three main types of non-surgical treatments that can beapplied in order to reduce visible wrinkles and sagging skin: (i) subtletightening, (ii) non-invasive (without skin penetration) and (iii)minimally invasive treatments (with skin penetration).

-   i. Subtle tightening    -   A subtle superficial tightening can be achieved by means of        skin-firming creams and lotions that provide mainly a        moisturizing effect into the skin that can plump up the        epidermis, making fine lines and wrinkles less noticeable. Some        cosmetic products incorporate substances such as retinol that        can help in the production of collagen. However, the results of        skin-firming creams and lotions are very subtle and temporary.    -   Other cosmetic non-surgical treatments such as the use of steam,        exfoliation, extraction, facial masks, peels, and massage also        exert an influence on the epidermis (the outer layer of the        skin) and therefore their effect might not have a substantial        impact on the appearance of skin or in the reduction of visible        wrinkles, having only a subtle result.-   ii. Non-invasive skin tightening procedures with production of heat    from the outside that passes through the epidermis in order to reach    the inner layer of the skin (dermis)    -   These procedures are called non-invasive because they do not        require making a puncture wound or incision. However, these        procedures might create redness and swelling on the outer layer        of the skin, which can last several days.    -   Non-invasive skin-tightening procedures allow for results that        tend to appear gradually, so they seem natural and usually they        take about one hour or less to be completed. These treatments        are focused on generating a “controlled damage” of the skin, to        boost skin regeneration for example.    -   The most common non-invasive skin tightening procedures are        ultrasound, radiofrequency and laser procedures, where each of        these types of procedures consists of applying heat or        irradiating heat to the skin from the outside layer (epidermis)        to boost the production of collagen. Therefore, while these        procedures aim at directing the heat to the dermis, the        treatments are performed from the outside (from the epidermis),        generally by means of a device that is placed against the skin.        Accordingly, the heat passes through the epidermis in order to        reach the inner layer of the skin (dermis). With one treatment,        most people see modest lifting with limited results within 2 to        6 months.-   iii. Minimally invasive skin tightening procedures through heat    irradiation or direct heat application in the dermis    -   There are two types of minimally invasive skin tightening        procedures that rely on heat applied or irradiated directly to        the dermis, specifically:    -   i) Laser treatments that aim at producing laser beams that        penetrate the skin and can reach the inner layer of the skin        (dermis) to heat it directly, such as Fraxel® and Co2re® where        laser beams are produced such that they penetrate the skin and        reach the dermis layer. This type of treatment does not entail a        physical penetration of the skin, but the laser beam penetrates        without needing a puncture or incision.    -   ii) Treatments where a device or apparatus is physically        introduced through the epidermis in order to reach the dermis.        For example, needles or probes are introduced in the skin in        order to reach the dermis, and then the heat is irradiated or        applied directly at the dermis layer.    -   From these types of procedures that aim at heating the dermis        layer directly, the ones that are more effective are the        treatments where probes or needles are introduced through the        epidermis to reach the dermis layer, which are able to provide a        direct physical contact between the probe or needle with the        dermis to provide heat irradiation or direct heat application.        These procedures are believed to represent the state of the art        in terms of this field.    -   For example, when a probe is used, the probe itself can        irradiate heat or apply heat directly to the dermis, as its        material or configuration allows for it. For example, the        material of a probe can be an electrode that produces a        radiofrequency at the extreme or distal end of the probe through        a direct cable/conductor connected to the probe.    -   In comparison to the non-invasive skin tightening procedures        (e.g., without skin penetration) that rely on applying heat to        the outer layer of the skin to hopefully reach the inner layer        to promote collagen denaturation (tightening), minimally        invasive skin tightening procedures that can heat the dermis        directly through insertion of probes or needles are able to        provide better and more noticeable results since they produce a        direct effect in the inner layers of the skin, while boosting        localized collagen and elastin production.

It is important to highlight that most of the aforementioned proceduresaim at irradiating the dermis through radiofrequency or applying heatdirectly to the dermis, which can boost the production of collagen andelastin in order to reduce wrinkling and sagging of the skin moreefficiently. By applying heat directly in the dermis, collagendenaturation occurs. Denaturation of collagen is the phenomenon ofthermal shrinkage of collagen, which begins with a denaturation of thetriple helix of the collagen molecule. When collagen is heated, theheat-labile intramolecular cross-links are broken, and the proteinundergoes a transition to a random, gel-like state (denaturation).Collagen shrinkage occurs through the cumulative effect of the“unwinding” of the triple helix, due to the destruction of theheat-labile intramolecular crosslinks, and the residual tension of theheat-stable intermolecular cross-links. Heated fibroblasts are alsoimplicated in new collagen formation and subsequent tissue remodelingwhich can also contribute to the final cosmetic result. The preciseheat-induced behavior of connective tissues and the extent of tissueshrinkage are dependent on several factors which include the maximumtemperature reached, exposure time, tissue hydration and tissue age.

The big difference between treatments applied in the outer layer of theskin (epidermis) or inner layer of the skin (dermis) is that the onesthat are able to heat the inner layer of the skin directly are moreefficient, as they heat the zone where collagen is produced, instead ofhaving to heat the outer layer (epidermis) in order to reach the innerlayers of the skin, which causes redness and sometimes mild burning ofthe epidermis.

Therefore, treatments that aim at heating the dermis directly by usingneedles and probes that are in direct physical contact with the dermisare more efficient, and there are two main types in the market todaythat are based on the use of radiofrequency:

A. Microneedling:

Microneedling refers to a treatment where a series of insulated smallsized needles are used to penetrate the skin and release radiofrequencycurrents from the needle tips producing thermal zones in the dermalstructural components. This process is known to trigger long-term dermalremodeling, neoelastogenesis, and neocollagenesis. The depth of theneedles varies from 0.5 mm to 3.5 mm which allows targeting differentlayers of the dermis. In one example, the main radiofrequency deliverysystem has a disposable tip with 49 gold plated needles. Thismicroneedling radiofrequency (MNRF) technology does not produce heatdirectly on the epidermis but on the dermis.

The microneedling treatment is a long treatment that generally commenceswith a local topic anesthetic being applied to the epidermis, such as ananesthetic cream that is applied and then produces a mild numbing effectgenerally within 30 to 45 minutes. Afterwards, anesthetic shots areadministered to the area being treated, where the anesthetic (generallylidocaine) is applied by a simultaneous 3-point application syringe thatadministers anesthetic to three points at the same time. Suchapplication is usually replicated throughout the entire skin surfacebeing treated (such as the neck and face), at least 10 times. This meansthat, for example, 3 shots are administered at least 10 times, resultingin at least 30 painful anesthetic shots being applied to a patient. Inother cases, simultaneous 5-point application syringes are used,increasing the amount of shots for the anesthesia application.

Therefore, this treatment takes a long time due to the application ofthe first topic anesthetic, and then for the additional simultaneous3-point (or 5-point) anesthetic application that is applied to the skinsurface.

In addition, since the microneedling device has 49 independent needles,each application of the device to the skin creates an additional 49punctures that may produce pain. As an example, a typical cheektreatment requires more than 5 device applications, resulting in morethan 245 punctures in the skin from the microneedles (not counting thepreviously applied anesthetic punctures on the skin).

Further, the anesthetic that is applied through the 3-point (or 5-point)simultaneous applicator syringe is not homogeneous. This in turn resultsin the numbness of the skin being non-homogeneous and can result in someapplications of the microneedling device being painless and some beingvery painful. The non-homogeneity causes discomfort and tension in thepatient vis-à-vis being worried if the next application of themicroneedling device will be painful or not.

Additionally, the microneedling device works in a relatively randomoperation and does not produce lineal contractions of the skin, but onlyworks on very specific application points where it is used and where themicroneedle is located.

Finally, the device and equipment used to apply these microneedlingtechniques are sophisticated and expensive, resulting in expensivetreatments that including the application of anesthetics can lastgenerally of up to 2 hours and generally has a cost of between USD$3,000 to USD $5,000 depending on the area to be treated.

B. Percutaneous Heating Probe:

This technique for face skin rejuvenation comprises the use of a probethat is introduced underneath the skin into the dermis layer in order toadminister radiofrequency directly to the dermis and subdermal tissuethrough manual displacement of the probe around the face and neck areas(among other areas of the body).

This treatment requires introducing a probe that has a tip thatirradiates heat through radiofrequency and therefore by moving the probethrough the dermis, the probe's tip irradiates the dermis layer throughradiofrequency and heats that local area. Subdermal temperatures aremonitored and controlled by a thermistor integrated within thethermocoupled handpiece. Concurrently, epidermal temperatures aremonitored using an infrared camera system. According to this treatment,both subdermal and dermal collagenous tissues reach therapeutictemperature thresholds necessary for collagen remodeling.

This treatment usually requires a first step of topic anestheticapplication (similarly than in microneedling techniques), where a localtopic anesthetic is applied to the epidermis, such as an anestheticcream that is applied and then produces a mild numbing effect within 30to 45 minutes.

Afterwards, anesthetic shots are administered to the area being treated,where the anesthetic (generally lidocaine) is applied by a simultaneous3-point application syringe that allows to administer the anesthetic tothree points at the same time, and such application is replicatedthroughout the entire skin surface being treated, at least 10 or even 20to 30 times in the case of face and neck applications. In other cases,simultaneous 5-point application syringes are used, increasing theamount of shots for the anesthesia application.

Since the anesthetic that is applied through the 3-point (or 5-point)simultaneous applicator syringe is not homogeneous, which causes thatthe numbness of the skin is non homogeneous, this can result in someperforations and heat application from the probe to be very painful,which also generates discomfort and tension in the patient that isworried if the next application of the heating probe will be painful ornot. This treatment also may take up to 2 hours including the timeneeded for the anesthetic to be applied.

Particularly for this type of treatment, since the probe is inserted andthen is displaced and moved manually through the dermis (under theskin), the treatment may damage blood vessels or nerves that are locatedunder the skin and generates an additional and important risk to thepatient. Additionally, improper manipulation may also create severeburns.

The device and moving probe are also sophisticated and expensivesystems, resulting in expensive treatments with a cost generally betweenUSD $3,500 to USD $5,000 depending on the area to be treated.

Therefore, the two aforementioned techniques designed to deliver RFenergy to the dermis layer of the skin apart from being expensive, arevery painful and generally require lengthy treatment periods in order toprovide a first anesthetic application that can be painful.

Other types of treatments that have not reached successful commercialapplication due to their complexity and high costs include the use ofmultiple implants that carry heater segments that are heated mainlythrough electromagnetism with very complex equipment, and that areinserted in the skin so that they are located in the interface betweenthe dermis and the fatty layer of the skin, and aim at providing directheating of the dermis layer of the skin to achieve a specific percentageof linear collagen shrinkage.

Therefore, even though commercial techniques to rejuvenate skin thatutilize irradiated radiofrequency to generate heat in the dermis layerof the skin via micro needling or moving probes have proved to be moreefficient than non-invasive treatments, they still show a number ofdrawbacks associated to such techniques.

Accordingly, there is a demand for cosmetic procedures to reduce thevisible effects of such skin distortions including a large demand for“tightening” skin to remove sags and wrinkles especially in the regionsof the face and neck. Furthermore, new systems are sought that canstimulate collagen production and subsequent tightening without causingvisible damage to the epidermis of the skin, without requiring largeapplication of topical and subcutaneous anesthetics, that are painless,have simple configurations, and that are inexpensive procedures thatallow a controlled and linear heating of the dermis layer of the skin toachieve said collagen stimulation with improved and longer lastingresults.

Therefore, according to one aspect of the invention, there is provided alow cost minimally invasive apparatus for tightening sagging skin bylinear tensing and stimulation of collagen production, which allows toadminister fluids such as anesthetics and optionally other treatmentfluids through the same apparatus. The apparatus comprises an insertableenergy transfer device having an elongated shape, wherein the device hasa hollow body, a tip, and a base and includes at least one orificelocated in the body or tip of the energy transfer device, through whichan effective amount of an anesthetic and optionally other treatmentfluids can be administered into a dermal layer of a patient and atemperature sensor located in the energy transfer device that measuresthe temperature of the dermis in immediate contact with the energytransfer device. The apparatus also includes an external generationdevice configured to generate energy that is transferred to the energytransfer device.

According to another aspect of the invention, there is provided a lowcost minimally invasive linear tensing cosmetic method for tighteningsagging skin by linear tensing and stimulation of collagen production byapplying heat to the dermis layer of the skin directly, which comprisesthe following steps:

-   -   a) providing an energy transfer device with an elongated shape        and a hollow body, comprising at least one orifice located        within the body or tip of the energy transfer device;    -   b) inserting the energy transfer device into a dermal layer of a        patient's skin;    -   c) administering an effective amount of anesthetic into a dermal        layer of a patient through the at least one orifice located in        the body or tip of the energy transfer device;    -   d) generating energy through an external generation device,        wherein such energy is transferred into the energy transfer        device in order to apply heat to the dermis layer of the skin;    -   e) measuring the temperature of the dermis that is in immediate        contact with the energy transfer device through a temperature        sensor located within the energy transfer device;    -   f) controlling the external generation device so that the energy        transfer device allows to heat the dermis layer up to a        temperature of between 45° to 75° C.;    -   g) maintaining the minimum temperature generated in the dermis        in immediate contact with the energy transfer device for a time        of up to 10 minutes;    -   h) cooling the patient's skin in the vicinity of the treatment        area;    -   i) repeating steps c. through h. as necessary, taking advantage        of the already introduced energy transfer device in contact with        the dermis layer of the skin; and    -   j) removing the energy transfer device from the skin.

While the invention will be described with respect to preferredembodiment configurations and with respect to particular components andstructures, it will be understood that the invention is not to beconstrued as limited in any manner by either such components orstructures described herein. Instead, the principles of this inventionextend to any method and apparatus in accordance with the claims.

These and other variations of the invention will become apparent tothose skilled in the art upon a more detailed description of theinvention. The advantages and features which characterize the inventionare pointed out with particularity in the claims annexed hereto andforming a part hereof. For a better understanding of the invention,however, reference should be had to the drawings which form a parthereof and to the accompanying descriptive matter, in which there isillustrated and described a preferred embodiment of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

Referring to the drawings, wherein like numerals represent like partsthroughout the several views:

FIG. 1 shows a previous art plot of linear shrinkage versus time forvarious temperatures.

FIG. 2 shows a representative distribution of the main layers of thehuman skin (3) including the epidermis (4), the dermis (5) and the fattissue (6).

FIG. 3 shows a first representative method (1) according to theprinciples of the present invention, wherein it is appreciated thatsteps 1 c through 1 h can be performed in a different order.

FIG. 4 shows a representative embodiment of the energy transfer device(7) wherein the device is hollow and includes a base (10), a tip (9), aheating element (8), and at least one orifice (12).

FIG. 5 shows another representative embodiment of the energy transferdevice (7) wherein the device is hollow and includes a base (10), a tip(9), a heating element (8), and a plurality of orifices (12).

FIG. 6 shows a representative embodiment of a handheld device (2)comprising an energy transfer device (7) with a plurality of orifices(12). The external generation device (13) is also shown, as well asfluid storage elements (14) that are connected to the energy transferdevice in order to allow administering treatment fluids contained withinthe fluid storage elements (14) to the dermis layer of the skin.

DESCRIPTION OF THE INVENTION

The present invention relates to the field of minimally invasivecosmetic procedures for improving the laxity of the skin and to delaythe signs of aging in humans. In particular, the invention provides aninnovative low cost, relatively short procedure time, efficient, andpainless minimally invasive device and method for tightening saggingskin using linear tensing and stimulation of collagen production.

The effects of dermal heating are well-recognized and include immediateeffects on collagen structure with stimulation of dermal fibroblastsinducing a synthesis of new collagen fibers (known as neocollagenesis)and elastic fibers (known as neoelastogenesis).

The present invention allows heating the dermis layer of the skin in acontrolled and efficient manner, thereby avoiding the limitations,problems and risks associated with current commercially appliedsolutions. The current solutions, as previously mentioned, usuallyrequire the use of a topical anesthetic that takes a long time to takeeffect. Then, a subcutaneous application of anesthetic step isperformed, which requires many painful punctures in the treatment areaand does not create a homogeneous effect. These drawbacks result in along total treatment time, difficulty in repeating the treatment in thesame location, requiring different devices and applications for theanesthesia (e.g., the anesthetic is not applied through the sametreatment apparatus), and do not allow administering anti-inflammatory,anti-bruising, or other collagen induction fluids in the same pointwhere the treatment is performed. Finally, the equipment and devicesused for current treatments are very expensive and complex.

For example, in the case of current techniques such as microneedling andmoving probe techniques, such techniques: have long anestheticapplication and procedure duration; require a large number of puncturesfor anesthetic application; are prone to risks of moving a probe underthe skin that can damage blood vessels or nerves or even generateserious burns (for moving probe techniques); may cause unexpectedpainful treatment due to non-homogeneous anesthetic application; do nothave a lineal tensing effect; and have very high equipment costs withcomplex configurations.

Embodiments constructed in accordance with the present inventionovercome the previous problems and limitations, and provide aninnovative apparatus and method that improves the results of skintightening by using heat that is directly applied to the dermis layer ofthe skin by having an energy transfer device that is inserted throughthe skin in order to reach the dermis layer and applies heat into suchlayer directly, allowing a precise temperature and application timecontrol, as well as providing linear tensing effects, wherein in a veryinnovative manner compared to current treatments, the anesthetic is alsoapplied directly through the apparatus in the same location that thetreatment is being performed, representing a revolutionary and importantchange in this field that may generate a very big impact in the market.As an additional innovative and surprising effect, the treatment of thepresent invention can be repeated in the same location with differentcombinations of temperature and time, and can also include theadministration of other treatment fluids such as anti-inflammatory,anti-bruising, or skin tightening treatment substances, which alsocontrasts with current techniques that do not encompass these steps.

It is important to mention that none of the abovementioned techniques,such as microneedling or moving probes, allow repeating the treatment inthe same location, or applying anesthetics through the same apparatus,or administering other fluids such as anti-inflammatory, anti-bruising,or collagen induction fluids through the same apparatus and in the samelocation where the treatment was performed.

In particular, the apparatus and method of the invention aim tostimulate collagen and elastin to generate subsequent tightening of theskin without causing visible damage to the epidermis of the skin andwithout requiring a long and painful application of anesthetics, in ashort, painless and inexpensive procedure that allows a controlled,linear tensing through heating of the dermis layer of the skin directlyin order to achieve said collagen stimulation with improved and longerlasting results, overcoming the drawbacks from current technologies, aswell as providing a new and innovative methods and apparatus that allowto administer not only anesthetics through the same device, but alsoallows to administer additional treatment fluids to the skin area thatis being treated during the treatment process. Further, the method andapparatus of the present invention allow repeating the treatment in thesame location as necessary, having many advantages over currenttreatment procedures.

Additionally, the method of the present invention allows evaluating theshrinkage rate and aesthetic view of the lineal tensing of the skin inreal time, allowing the technician to determine if the treatment needsto be repeated in the same location and to determine the temperature andtreatment time to be applied on a specific patient. This is an importantfeature as current techniques such as microneedling do not allowvisually evaluating the shrinkage rate but those treatments have to waitseveral weeks to provide the full effect. None of the currentcommercially applied methods allow to visualize and evaluate the linealshrinkage of the skin in real time in order to determine next steps ofthe treatment. It's important to note that this shrinkage rate andvisualized shrinkage will be part of the total shrinkage rate achievedin the skin.

Description of the Apparatus

The unique apparatus of the present invention allows heating the dermislayer of the skin directly, in order to tighten sagging skin by lineartensing and stimulation of collagen production. The apparatus accordingto the principles of the present invention not only addresses thedrawbacks of minimally invasive procedures that are commercially used,such as microneedling or moving probes, but also in an innovative mannerallows the technician to apply the anesthetic in a localized manner andin the precise spot where the heat is being applied. In addition, theapparatus according to the present invention can allow theadministration not only of anesthetics previous or during the procedure,but also of treatment fluids such as anti-inflammatory, anti-bruising,or other collagen promotion fluids at any time during the treatmentprocess.

An apparatus in accordance with the principles of the present inventioncomprises an energy transfer device having an elongated shape and thathas a base and a body, wherein the length of its body is at least 1 cm,which allows the technician to insert the device in the patient's skinand to reach at least the dermal layer of the same. The energy transferdevice has an elongated shape like a hollow cannula or needle thatallows introducing a fluid substance through the same. The energytransfer device comprise anti-allergen materials to minimize risk ofgenerating an allergic reaction when introduced to the patient's skin.

In an embodiment of the invention, the energy transfer device is ahollow cannula that is introduced through the skin by means of anintroducing device or needle, typically used in cannulas. In anotherembodiment of the invention, the energy transfer device has a pointedtip for allowing its introduction to the skin, such as a needle orsyringe. The needle or syringe may be constructed so that it can besterilized by conventional sterilization techniques or can be disposableelements.

The energy transfer device may comprise a textured surface to achievefocalized energy transfer into the dermis layer of the skin. Forexample, the energy transfer device may comprise spiral or helicoidallyconfigured protrusions that generate a spring-like effect on the skinwhen such spirals transfer energy into the dermis layer of the skin.

In another embodiment of the invention, the energy transfer devicecomprises elements or materials located in the inside or embedded intothe energy transfer device, and that have an helicoidally configuredpattern that cause heating through such elements or materials andtherefore generates a spring-like effect on the skin when such materialsor elements transfer energy into the dermis layer of the skin. In thisembodiment, the materials or elements within the energy transfer devicedo not generate any protrusions or texture of the device.

In an embodiment of the invention, the energy transfer device compriseflexible materials so as to adapt to contours of the skin and/or toachieve easier introduction into the dermis layer of the skin, Inanother embodiment of the invention, the energy transfer devicecomprises rigid materials to maintain its shape and design whileintroduced to the skin.

Also, in an embodiment of the invention, double-walled cannulas orneedles may be used.

In a preferred embodiment of the invention, at least a portion of thedevice comprises a heating element that is able to increase itstemperature.

In a more preferred embodiment of the invention, the heating element canbe an electrically conductive material that increases its temperature inresponse to an electrical current passing through a resistive element,coil, or by other similar means exhibiting electrical resistance. Suchelectrically conductive material can be used for more intense or lessintense treatments, depending on its configuration. This embodimentrequires a physical connection between the energy transfer device andexternal generation equipment capable of generating the current neededfor increasing the temperature of the heating element in a controlledmanner. It is important to note than when conductive materials are used,the energy transfer device is configured so that a portion of it acts asa thermal insulator in order to avoid the heat to be transmitted andconducted to other portions of the skin. In an embodiment of theinvention, when using a cannula or similar device, such device isconstructed so it has an insulated section that allows the circulationof electricity through the heating element. The energy transfer deviceand its heating element are configured to achieve a substantiallyhomogeneous temperature across the introduced portion of the device.

Alternatively, the heating element can be an electromagneticallyinducible material, which means that is able to increase its temperaturein response to an electromagnetic field in its vicinity, also known asinduction heating. For the purposes of the present embodiment of theinvention, the electromagnetically inducible material that covers atleast a portion of the energy transfer device is a ferromagneticmaterial with a Curie temperature of at least 300 K.

When electromagnetically inducible material is used, the inducercomprises equipment and systems that are placed over the skin orsurrounding the skin where the energy transfer device is introduced inorder to achieve a substantially homogeneous temperature of the energytransfer device in such zone.

The heating element is configured so that it allows applying atemperature of between 45 and 75 degrees Celsius for a time rangedepending on the treatment intensity, with a maximum application time of10 minutes, which can be achieved in either one application or insubsequent applications.

In a related embodiment of the invention, the energy transfer devicealso comprises a portion that is constructed with a material that is notable to be heated and/or that does not increase its temperaturesubstantially, in order to protect the skin in the insertion point. Inanother embodiment of the invention, the heating element covers amajority of the body of the device except for the base, which is made ofa non-heating element that does not increase its temperaturesubstantially. This is of particular importance since the base may stayin contact with the epidermis before, during and after the applicationprocedure and create undesired burns in the surrounding areas when heatis being applied to the dermis layer of the skin.

Further, in other embodiments of the invention, and in order to achievemore intense treatments with shorter times and higher temperatures, theenergy transfer device may comprise laser, radiofrequency, or ultrasoundapplication elements.

The apparatus of the invention provides a linear tensing effect throughcontrolled heating of the dermis layer of the skin and may not requirethe technician to manipulate the device and move it through the skin.Movement through the skin can cause uneven results in the zone where theheat is applied such as in the aforementioned moving irradiation probetechniques.

The apparatus of the present invention generates a lineal tensing effecton the skin by applying heat to the dermis layer of the skin through alow cost, short duration, and painless method, wherein the apparatusalso applies anesthetics through the same device, as well as allowingthe application of other treatment fluids such as anti-inflammatory,anti-bruising, and/or collagen inductors that are applied in the samelocation of the treatment, representing an incomparable advantage andnew feature compared to current treatments. Further, the apparatus canbe used several times in the same spot to repeat the treatment asneeded, which also cannot be achieved by current commercial apparatus.

Accordingly, the present invention provides a minimally invasivecosmetic procedure for improving the laxity of the skin and to delay thesigns of aging in humans. In particular, the invention provides aninnovative low cost, short time, and painless minimally invasive deviceand method for tightening sagging skin by means of linear tensing andstimulation of collagen production, wherein the apparatus not onlyallows to apply direct heat in the dermis layer of the skin, but alsoallows to administer an anesthetic and optionally additional treatmentfluids such as anti-inflammatory, anti-bruising, or collagen inductionfluids through the same apparatus.

In a very innovative manner, and in a completely different configurationthan all known current and previous treatments performed commerciallyaround the world, the energy transfer device in accordance with thepresent invention comprises a hollow device, wherein the device includesat least one orifice through which several substances can be inserteddirectly into the dermis layer of the patient. This feature has severaladvantages over current treatment apparatus and methods, and creates acompletely new field of skin tightening processes that can achieve lowertreatment times, less painful experiences, and a more controlled tensingeffect of the skin. In an embodiment of the invention, the energytransfer device comprises a plurality of orifices to administer theanesthetic or other treatment fluids.

The energy transfer device further includes a temperature sensor locatedin the device that measures the temperature of the dermis immediately incontact with the energy transfer device. Therefore, this sensor allowsthe technician to ascertain the moment that the desired temperature isreached and to control the amount of time that said temperature will bemaintained in order to provide the desired shrinkage rates. The sensorcan be selected from thermocouples, thermistors, infrared sensors andthermometers, among others.

An external generation device is also provided as part of the apparatusof the present invention, wherein the external generation device isconfigured to provide the type of energy required to allow the energytransfer device to apply heat in the dermis layer.

In an embodiment of the invention where a heating element is used withinthe energy transfer device, the external generation device is configuredto generate a magnetic field by generating high-frequency alternatingelectrical currents from 500 KHz to 10 MHz, in order to provideinduction heating to the electromagnetically inducible material of theheating element.

In another embodiment of the invention where a heating element is usedwithin the energy transfer device, the external generation devicegenerates an electric current that is transferred to the heating elementof the energy transfer device through a physical connection, such as acable, wire, conductive cord, among others.

In other embodiments of the invention where the energy transfer devicecomprises a laser, ultrasound, or radiofrequency applicators, theexternal generation device is suitably configured to provide therequired energy for such application, allowing to power the laser,ultrasound, or radiofrequency applicator located in the energy transferdevice.

The apparatus of the invention can further comprise an externaltemperature control device configured to detect the temperature reachedin the zone of the skin where the device is inserted. The externaltemperature control device comprises infrared cameras, among others.

In addition, the apparatus of the invention can further comprise coolingmeans that allow lowering the temperature of the device upon applying ahigh temperature to the patient's skin and that can operate while theprocedure is being performed. In an embodiment, the cooling means is adevice that applies cold air that allows for a rapid cooling of the skinupon application of temperature to the dermis. In other alternativeembodiments, the cooling means is an external device or element thatlowers the temperature of the skin such cold compresses or through theuse of cold fluids. In another embodiment of the invention, a coolingfluid can be administered through the device or put in direct contactwith the dermis or epidermis while inserted in the skin, to achievelocalized cooling of such treatment area. In a further embodiment of theinvention, the skin can be cooled off naturally over time.

Description Of The Method

The present invention aims to provide a low cost minimally invasivelinear tensing cosmetic method for delaying the signs of aging on apatient's skin, where the method comprises providing an energy transferdevice for applying direct heat to the dermis. The energy transferdevice is inserted into a dermal layer of a patient's skin, wherein theenergy transfer device has an elongated shape like a hollow cannula orneedle in order to allow introducing a fluid substance through the same.The energy transfer device is inserted into the patient's skin up to alength based on the area of the body where the treatment is beingperformed.

An external generation device is also provided as part of the apparatusaccording to the present invention, wherein the device is configured toprovide the required type of energy according to the type of heatingperformed by the energy transfer device. In embodiments where the energytransfer device includes a heating element that increases itstemperature to provide direct heating to the dermis through conduction,the external generation device is configured to generate an electriccurrent or a magnetic field that allows increasing the temperature ofthe heating element located within the energy transfer device. In otherembodiments of the invention, the external generation device allowspowering a laser, ultrasound, or radiofrequency applicator located inthe energy transfer device.

The method of the present invention requires the application of heat inthe dermis layer of the skin through the energy transfer device, andcomprises controlling the temperature and time of the heat applicationso that the dermis layer that is in direct contact with the energytransfer device achieves a temperature of between 45 and 75 degreesCelsius for a time range of up to 10 minutes.

The temperature of the dermis layer in immediate direct contact with theenergy transfer device is measured through a temperature sensor locatedwithin the energy transfer device.

As seen in FIG. 1, previous experimental studies performed over theyears have found that shrinking of collagen in the dermis depends on theapplied temperature and the application time, where for example in onespecific type of skin, a temperature of 62.5° C. maintained during about10 minutes generates a 30% linear shrinkage, wherein maintaining 65.5°C. for about 1 minute generates a 20% linear shrinkage. In comparison,the same 20% can be achieved by maintaining 59.5° C. for about 20minutes.

The method of the present invention requires the application of heat inthe dermis layer of the skin through the energy transfer device,comprising controlling the temperature and time of the heating elementlocated within the energy transfer device so that the dermis layer thatis in direct contact with the energy transfer device achieves ashrinkage rate of between 5-35%.

Also as an important and innovative feature, the method of the presentinvention allows evaluating the shrinkage rate and aesthetic view of thelineal tensing of the skin in real time, allowing the technician todetermine if the treatment needs to be repeated in the same location andto determine the temperature and treatment time to be applied on aspecific patient. This is an important feature as current techniquessuch as microneedling do not allow visually evaluating the shrinkagerate but those treatments have to wait several weeks to provide the fulleffect. None of the current commercially applied methods allow tovisualize and evaluate the lineal shrinkage of the skin in real time inorder to determine next steps of the treatment.

The method of the present invention can be separated into two mainareas, one where the treatment is intense and aims at producing hightemperature applications during short periods of time (of less than 5seconds), and the other where the treatment is less intense and aims atproducing lower temperature applications for longer time periods (ofmore than 5 seconds and up to 10 minutes). Both treatment intensitiesdepend on the energy transfer device and if it comprises a heatingelement (heated through electric conduction or electromagnetism) orother heat applicators such as lasers, ultrasound, or radiofrequencyapplicators.

In certain embodiments, and dependent on the specific conditions of thepatient and the practitioner's technique, a shrinkage rate of between5-35% can be achieved by applying a temperature of between 45 and 75degrees Celsius for a time range depending on the treatment intensity,with a maximum application time of 10 minutes, which can be achieved ineither one application or in subsequent applications.

As a very innovative and completely new feature of the presentinvention, the energy transfer device comprises at least one orificethrough which an effective amount of an anesthetic or other substancesis administered directly into the dermis layer during the treatmentprocess, using the same apparatus for heating the dermis and generatinga lineal tensing effect as well as for administering the anesthetic.Generally, the orifice is located within the body or tip of the energytransfer device. For example, an orifice located in the body or tip ofthe energy transfer device allows for a localized application of theanesthetic in the precise area where the application of temperature willtake place. This is an advantageous feature of the invention compared toother known techniques which apply a sedative in random areas of thetreatment location (e.g., a patient's face for example) causingunnecessary sedation and numbness in addition to the pain and discomfortduring the anesthetic procedure.

In addition, and as an innovative and surprising effect, the at leastone orifice also allows administering treatment fluids to the dermislayer of the patient after the procedure has been performed, wherein thetreatment fluids are selected from the group comprising collagen and/orcollagen inductors including but not limited to calcium hydroxyapatite,poly-L-lactic acid, and hyaluronic acid, an anti-inflammatory substance,an anti-bruising substance, and other type of substances that can helpin the treatment and/or recovery of the treated zone.

The method according to the principles of the present invention requiresat least one energy transfer device that is inserted into the skin andremains inserted during the treatment process. Advantageously, themethod also allows for the insertion of many energy transfer devicesinto the dermis layer of the skin, and afterwards the heating and/orfluid administration processes can be performed simultaneously on atleast two of the inserted energy transfer devices. The use of inserteddevices allows for performing longer heat application periods atrelatively low temperatures. In the case that multiple energy transferdevices are inserted, the apparatus is designed and configured to allowtheir simultaneous operation.

In another embodiment of the invention, the energy transfer device islocated in a handheld device that is used in a specific treatment zonewithin the skin once at a time. As seen in FIG. 06, a handheld device(2) is shown, wherein the handheld device comprises an energy transferdevice (7) with a plurality of orifices (12). The external generationdevice (13) is also shown, as well as fluid storage elements (14) thatare connected to the energy transfer device in order to allow theiradministration to the dermis layer of the skin. The external generationdevice transfers the energy (shown as arrow 14 in the Figure) to theenergy transfer device either by a physical connection, such as cablesor similar means, or through induction. This device allows performingshorter heat application periods at relatively higher temperatures.

In another embodiment of the invention, the energy transfer devicecomprises a plurality of orifices distributed through its body and/ortip in order to administer the anesthetics and optionally othertreatment fluids during the treatment process.

In an embodiment of the invention, the use of anesthetics such aslidocaine (mixed or not with epinephrine), conductive fluids, or othersubstances that would improve patient comfort or that would result in animproved post procedure cosmetic appearance of the tissue is preferred.A solution having a lidocaine concentration between 0.1% to 2%(preferably 0.25%), preferably mixed with epinephrine diluted to1:100,000 to 1:500,000 (preferably 1:400,000) is preferred. Dilutedlidocaine without epinephrine can also be used to suppress pain andimprove patient comfort.

The method of the present invention, in an innovative manner, providesfor repetition at the treatment site as many times as may be needed. Themethod of the present invention can repeated in the same treatment spotas required, without having to re-introduce a device. This is importantas when high temperatures are applied to the skin, serious burns mayresult, or even nerves can be damaged, and therefore by allowing torepeat the treatment in the same spot, lower temperatures can be used inseparate times, minimizing such risks. For example, the energy transferdevice is used to heat the dermis so that the skin reaches an averagetemperature of within 45 and 75° C. as a maximum, then the skin areawhere the energy transfer device is inserted is cooled off, and then theheating element is again heated and increases its temperature andtherefore allows heating the same dermis area to achieve a temperatureof within 45 and 75° C. for a predetermined period of time. Suitablecooling means comprise cold air, ice, cold compresses, or naturalcooling.

In a preferred embodiment of the invention, and before removing theenergy transfer device from the patients skin, the energy transferdevice can be cooled down through cooling means or naturally, andadditional anti-inflammatory, anti-bruising, or skin tighteningtreatment substances, such as collagen inductors, are applied to thedermis through the orifices located within the device, comprisingcollagen and/or collagen inductors including but not limited to calciumhydroxyapatite, poly-L-lactic acid, and hyaluronic acid, ananti-inflammatory and other type of substances that can help in thetreatment and/or recovery of the treated zone.

In another embodiment of the invention, the anti-inflammatory,anti-bruising, and/or skin tightening treatment substances such ascollagen inductors are applied simultaneously with the anesthetic duringthe treatment through the apparatus of the present invention.

The method is finalized when the energy transfer device is removed fromthe skin.

The treatment of the present invention can be applied in different partsof the body, comprising not only the face and neck but also the rest ofthe body.

The device of the present invention therefore solves majority of thetechnical drawbacks of the techniques known from the state of the art assummarized in the following table.

TABLE 1 Comparison from Present Invention with Microneedling TechniquesFeature Microneedling Present Invention Topical Anesthetic of Usuallyapplied Not necessary 30-45 minutes Multiple injection with About 60points Only one needed anesthetic (lidocaine) of application per eachenergy for conventional transfer device treatment insertion Certainty ofNot homogeneous, Yes - applied anesthesia creates painful precisely inthe insertion areas line of treatment Punctures for More than 200 totalNot needed irradiating heat punctures Time Approximately 2 Less thanhours including 40 minutes topic anesthesia Cost of equipment and HighLow treatment Lineal tensing No Yes Possibility of repeating Notdescribed Possible treatment in exactly same point Application ofanesthetic No Yes with same heating apparatus Application of anti- NoYes inflammatory and optionally collagen inductors in precise treatmentarea with the same heating apparatus Inflammation and bruising Mainly inall face Limited to the lines and neck (when of application andperformed in that allows to apply anti- location) inflammatory in thesame treatment spot Allows applying different No Yes combinations oftemperature and time in the same treatment location Allows to visualizelineal No Yes shrinkage rate in real time

TABLE 2 Comparison from Present Invention with Moving Irradiating ProbeTechniques Feature Microneedling Present Invention Topical Anesthetic ofUsually applied Not necessary 30-45 minutes Multiple injection withAbout 60 points Only one needed per anesthetic (lidocaine) ofapplication each energy transfer for conventional device insertiontreatment Certainty of Not homogeneous, Yes - applied anesthesia createsgenerates precisely in the painful insertion line of treatment areasTime Approximately 2 Less than hours including 40 minutes topicanesthesia Cost of equipment and High Low treatment Possibility ofrepeating Not described Possible treatment in exactly same pointApplication of anesthetic No Yes with same heating apparatus Applicationof anti- No Yes inflammatory and optionally collagen inductors inprecise treatment area with the same heating apparatus Inflammation andbruising Mainly in all face Limited to the lines and neck (when ofapplication, and performed in that allows to apply anti- location)inflammatory in the same treatment spot Possibility of damage toPossible Seldom possible tissue and nerves through moving heatedapparatus Allows applying different No Yes combinations of temperatureand time in the same treatment location Allows to visualize lineal NoYes shrinkage rate in real time

It is expressly intended that, wherever possible, the invention includescombinations of aspects of the various embodiments described herein oreven combinations of the embodiments themselves. Accordingly, othercomponents that embody the principles of this invention can beconfigured within the spirit and intent of this invention. Thearrangement described herein is provided as only one example of anembodiment that incorporates and practices the principles of thisinvention. Other modifications and alterations are well within theknowledge of those skilled in the art and are to be included within thebroad scope of the appended claims.

What is claimed is:
 1. A low cost minimally invasive apparatus fortightening sagging skin by linear tensing and stimulation of collagenproduction, which allows to administer fluids such as anesthetics andoptionally other treatment fluids through the same apparatus,comprising: an insertable energy transfer device having an elongatedshape, wherein the device has a hollow body, a tip, and a base andincludes: at least one orifice located in the body or tip of the energytransfer device, through which an effective amount of an anesthetic andoptionally other treatment fluids can be administered into a dermallayer of a patient; and a temperature sensor located in the energytransfer device that measures the temperature of the dermis in immediatecontact with the energy transfer device; and an external generationdevice configured to generate energy that is transferred to the energytransfer device.
 2. The apparatus according to claim 1, wherein the bodyof the energy transfer device is at least 1 cm long.
 3. The apparatusaccording to claim 1, wherein the body of the energy transfer device isa hollow cannula.
 4. The apparatus according to claim 1, wherein thebody of the energy transfer device is a needle or syringe.
 5. Theapparatus according to claim 1, wherein the body of the energy transferdevice has a double wall configuration.
 6. The apparatus according toclaim 1, wherein the body of the energy transfer device comprises atextured surface to achieve focalized energy transfer into the dermislayer of the skin.
 7. The apparatus according to claim 1, wherein thebody of the energy transfer device comprises spiral or helicoidallyconfigured protrusions that generate a spring-like effect on the skinwhen such spirals transfer energy into the dermis layer of the skin. 8.The apparatus according to claim 1, wherein the body of the energytransfer device comprises elements or materials located in the inside orembedded into the energy transfer device, and that have an helicoidallyconfigured pattern that cause heating through such elements or materialsand therefore generates a spring-like effect on the skin when suchmaterials or elements transfer energy into the dermis layer of the skin.9. The apparatus according to claim 1, wherein the body or tip of theenergy transfer device comprises a plurality of orifices to administer atreatment fluid to the dermis layer of the skin.
 10. The apparatusaccording to claim 1, wherein the treatment fluids comprise anesthetics,anti-inflammatory, anti-bruising, and/or collagen induction substances.11. The apparatus according to claim 1, wherein the energy transferdevice comprises a heating element covering at least one portion of thebody and/or tip of the energy transfer device, so that such material isable to increase its temperature in a controlled manner.
 12. Theapparatus according to claim 11, wherein the portion of the body notcovered with the heating element, is covered with a non-heating elementthat does not increase its temperature substantially to protect theinsertion point of the skin.
 13. The apparatus according to claim 11,wherein the heating element is constructed so that it increases itstemperature in response to an electrical current passing through aresistance that is generated by the external generation device.
 14. Theapparatus according to claim 11, wherein the heating element isconstructed so that it increases its temperature driven by electricitygenerated by the external generation device.
 15. The apparatus accordingto claim 11, wherein the heating element is constructed so that itincreases its temperature in response to an electromagnetic fieldgenerated by the external generation device.
 16. The apparatus accordingto claim 1, wherein the energy transfer device comprises lasers,radiofrequency irradiation, or ultrasound applicators in order to heatthe dermis layer of the skin.
 17. The apparatus according to claim 1,wherein the energy transfer device is configured so that a portion of itacts as a thermal insulator in order to avoid the heat to be transmittedand conducted to other portions of the skin.
 18. The apparatus accordingto claim 11, wherein the heating element covers the majority of the bodyof the device except for the base, which is made of a non-heatingelement that does not increase its temperature substantially.
 19. Theapparatus according to claim 1, wherein the energy transfer device islocated in a handheld device that is used in a specific treatment zonewithin the skin once at a time and allows performing shorter heatapplication periods at relatively higher temperatures.
 20. The apparatusaccording to claim 1, wherein the apparatus is designed and configuredto allow the simultaneous operation of at least two energy transferdevices that are inserted into the dermis layer of the skin.
 21. Theapparatus according to claim 1, wherein an external temperature controldevice is provided, such that the external temperature control device isconfigured to measure the temperature reached in the zone of the skinarea where the device is inserted.
 22. The apparatus according to claim1, wherein cooling means are provided in order to lower the temperatureof the skin of the patient.
 23. The apparatus according to claim 1,wherein the cooling means is selected from the group comprising coldair, ice, or cold compresses.
 24. The apparatus according to claim 1,wherein the cooling means is a cooling fluid administered through thedevice or put in direct contact with the dermis or epidermis whileinserted in the skin, to achieve localized cooling of such treatmentarea.
 25. The apparatus according to claim 1, wherein the externalgeneration device allows to generate energy that is transferred to theenergy transfer device, selected from the list comprising anelectromagnetic field generator, an electric current generator, aradiofrequency generator, a laser generator, or an ultrasound generator.26. The apparatus according to claim 1, wherein the external generationdevice transfers the energy to the energy transfer device either by aphysical connection, such as cables or similar means, or throughinduction.
 27. A low cost minimally invasive apparatus for tighteningsagging skin by linear tensing and stimulation of collagen production,which allows to administer fluids such as anesthetics and optionallyother treatment fluids through the same apparatus, comprising: aninsertable energy transfer device having an elongated shape, wherein thedevice has a hollow body, a tip, and a base and includes: a heatingelement covering at least one portion of the body and/or tip of theenergy transfer device, so that such material is able to increase itstemperature in a controlled manner; at least one orifice located in thebody or tip of the energy transfer device, through which an effectiveamount of an anesthetic and optionally other treatment fluids can beadministered into a dermal layer of a patient; and a temperature sensorlocated in the energy transfer device that measures the temperature ofthe dermis in immediate contact with the energy transfer device; and anexternal generation device configured to generate energy that istransferred to the energy transfer device in order to increase thetemperature of the heating element.
 28. The apparatus according to claim27, wherein the body of the energy transfer device is at least 1 cmlong.
 29. The apparatus according to claim 27, wherein the body of theenergy transfer device is a hollow cannula.
 30. The apparatus accordingto claim 27, wherein the body of the energy transfer device is a needleor syringe.
 31. The apparatus according to claim 27, wherein the body ofthe energy transfer device has a double wall configuration.
 32. Theapparatus according to claim 27, wherein the body of the energy transferdevice comprises a textured surface to achieve focalized energy transferinto the dermis layer of the skin.
 33. The apparatus according to claim27, wherein the body of the energy transfer device comprises spiral orhelicoidally configured protrusions that generate a spring-like effecton the skin when such spirals transfer energy into the dermis layer ofthe skin.
 34. The apparatus according to claim 27, wherein the body ofthe energy transfer device comprises elements or materials located inthe inside or embedded into the energy transfer device, and that have anhelicoidally configured pattern that cause heating through such elementsor materials and therefore generates a spring-like effect on the skinwhen such materials or elements transfer energy into the dermis layer ofthe skin.
 35. The apparatus according to claim 27, wherein the body ortip of the energy transfer device comprises a plurality of orifices toadminister a treatment fluid to the dermis layer of the skin.
 36. Theapparatus according to claim 27, wherein the treatment fluids compriseanesthetics, anti-inflammatory, anti-bruising, and/or collagen inductionsubstances.
 37. The apparatus according to claim 27, wherein the portionof the body not covered with the heating element, is covered with anon-heating element that does not increase its temperature substantiallyto protect the insertion point of the skin.
 38. The apparatus accordingto claim 27, wherein the heating element is constructed so that itincreases its temperature in response to an electrical current passingthrough a resistance that is generated by the external generationdevice.
 39. The apparatus according to claim 27, wherein the heatingelement is constructed so that it increases its temperature driven byelectricity generated by the external generation device.
 40. Theapparatus according to claim 27, wherein the heating element isconstructed so that it increases its temperature in response to anelectromagnetic field generated by the external generation device. 41.The apparatus according to claim 27, wherein the energy transfer deviceis configured so that a portion of it acts as a thermal insulator inorder to avoid the heat to be transmitted and conducted to otherportions of the skin.
 42. The apparatus according to claim 27, whereinthe heating element covers the majority of the body of the device exceptfor the base, which is made of a non-heating element that does notincrease its temperature substantially.
 43. The apparatus according toclaim 27, wherein the energy transfer device is located in a handhelddevice that is used in a specific treatment zone within the skin once ata time and allows performing shorter heat application periods atrelatively higher temperatures.
 44. The apparatus according to claim 27,wherein the apparatus is designed and configured to allow thesimultaneous operation of at least two energy transfer devices that areinserted into the dermis layer of the skin.
 45. The apparatus accordingto claim 27, wherein an external temperature control device is provided,such that the external temperature control device is configured tomeasure the temperature reached in the zone of the skin area where thedevice is inserted.
 46. The apparatus according to claim 27, whereincooling means are provided in order to lower the temperature of thepatient's skin.
 47. The apparatus according to claim 27, wherein thecooling means is selected from the group comprising cold air, ice, orcold compresses.
 48. The apparatus according to claim 27, wherein thecooling means is a cooling fluid administered through the device or putin direct contact with the dermis or epidermis while inserted in theskin, to achieve localized cooling of such treatment area.
 49. Theapparatus according to claim 27, wherein the external generation deviceallows to generate energy that is transferred to the energy transferdevice, selected from the list comprising an electromagnetic fieldgenerator, an electric current generator, a radiofrequency generator, alaser generator, or an ultrasound generator.
 50. The apparatus accordingto claim 27, wherein the external generation device transfers the energyto the energy transfer device either by a physical connection, such ascables or similar means, or through induction.
 51. A low cost minimallyinvasive linear tensing cosmetic method for tightening sagging skin bylinear tensing and stimulation of collagen production by applying heatto the dermis layer of the skin directly, which comprises the nextsteps: a) providing an energy transfer device with an elongated shapeand a hollow body, comprising at least one orifice located within thebody or tip of the energy transfer device; b) inserting the energytransfer device into a dermal layer of a patient's skin; c)administering an effective amount of anesthetic into a dermal layer of apatient through the at least one orifice located in the body or tip ofthe energy transfer device; d) generating energy through an externalgeneration device, wherein such energy is transferred into the energytransfer device in order to apply heat to the dermis layer of the skin;e) measuring the temperature of the dermis that is in immediate contactwith the energy transfer device through a temperature sensor locatedwithin the energy transfer device; f) controlling the externalgeneration device so that the energy transfer device allows to heat thedermis layer up to a temperature of between 45° to 75° C.; g)maintaining the minimum temperature generated in the dermis in immediatecontact with the energy transfer device for a time of up to 10 minutes;h) cooling the patient's skin in the vicinity of the treatment area; i)repeating steps c. through h. as necessary, taking advantage of thealready introduced energy transfer device in contact with the dermislayer of the skin; and j) removing the energy transfer device from theskin.
 52. The minimally invasive cosmetic method from claim 51, whereinat least a portion of the energy transfer device comprises a heatingelement that increases its temperature in a controlled manner.
 53. Theminimally invasive cosmetic method from claim 52, wherein the heatingelement of the energy transfer device is constructed so that itincreases its temperature in response to energy generated by theexternal generation device.
 54. The minimally invasive cosmetic methodfrom claim 53, wherein the external generation device allows to generateenergy that is transferred to the energy transfer device, selected fromthe list comprising an electromagnetic field generator, an electriccurrent generator, a radiofrequency generator, a laser generator, or anultrasound generator.
 55. The minimally invasive cosmetic method fromclaim 51, wherein by controlling the temperature and time of the heatapplication from the energy transfer device, the dermis layer that is indirect contact with the energy transfer device achieves a shrinkage rateof between 5-35%.
 56. The minimally invasive cosmetic method from claim55, wherein the shrinkage rate can be achieved in one or multipleapplications.
 57. The minimally invasive cosmetic method from claim 51,wherein the technician is able to visualize and evaluate the linealshrinkage of the skin in real time in order to determine next steps ofthe treatment.
 58. The minimally invasive cosmetic method from claim 51,wherein two or more energy transfer devices are inserted into the dermislayer of the skin, and afterwards the heating and/or fluidadministration processes can be performed simultaneously on at least twoof the inserted energy transfer devices.
 59. The minimally invasivecosmetic method from claim 51, wherein the anesthetic comprises asolution having a lidocaine concentration between 0.1% to 2%.
 60. Theminimally invasive cosmetic method from claim 51, wherein the anestheticcomprises a solution having a lidocaine concentration between 0.1% to 2%that is mixed with epinephrine diluted to 1:100,000 to 1:500,000. 61.The minimally invasive cosmetic method from claim 51, wherein the methodcomprises administering additional treatment substances through the atleast one orifice in the energy transfer device.
 62. The minimallyinvasive cosmetic method from claim 61, wherein the treatment substancescomprise collagen and/or collagen inductors including but not limited tocalcium hydroxyapatite, poly-L-lactic acid, and hyaluronic acid, ananti-inflammatory, an anti-bruising substance, and other type ofsubstances that can help in the treatment and/or recovery of the treatedzone.
 63. The minimally invasive cosmetic method from claim 51, whereinthe anesthetic is mixed with the treatment fluids and administeredsimultaneously through the energy transfer device.
 64. The minimallyinvasive cosmetic method from claim 51, wherein the cooling of the skinis performed with cooling means that comprise cold air, ice, or coldcompresses.
 65. The minimally invasive cosmetic method from claim 51,wherein the cooling of the skin does not require external cooling meansbut is done naturally.
 66. The minimally invasive cosmetic method fromclaim 51, wherein the cooling means is a cooling fluid administeredthrough the device or put in direct contact with the dermis or epidermiswhile inserted in the skin, to achieve localized cooling of suchtreatment area.
 67. The minimally invasive cosmetic method from claim51, wherein the method can be applied to the face and neck, as well asto other body parts.
 68. A low cost minimally invasive linear tensingcosmetic method for tightening sagging skin by linear tensing andstimulation of collagen production by applying heat to the dermis layerof the skin directly, which comprises the next steps: a) providing anenergy transfer device with an elongated shape and a hollow body,comprising at least one orifice located within the body or tip of theenergy transfer device, wherein at least a portion of the energytransfer device comprises a heating element that increases itstemperature in a controlled manner; b) inserting the energy transferdevice into a dermal layer of a patient's skin; c) administering aneffective amount of anesthetic into a dermal layer of a patient throughthe at least one orifice located in the body or tip of the energytransfer device; d) generating energy through an external generationdevice, wherein such energy is transferred into the energy transferdevice in order to apply heat to the dermis layer of the skin byincreasing the temperature of the heating element; e) measuring thetemperature of the dermis that is in immediate contact with the energytransfer device through a temperature sensor located within the energytransfer device; f) controlling the external generation device so thatthe energy transfer device allows to heat the dermis layer up to atemperature of between 45° to 75° C.; g) maintaining the minimumtemperature generated in the dermis in immediate contact with the energytransfer device for a time of up to 10 minutes; h) cooling the patient'sskin in the vicinity of the treatment area; i) repeating steps c.through h. as necessary, taking advantage of the already introducedenergy transfer device in contact with the dermis layer of the skin; andj) removing the energy transfer device from the skin.
 69. The minimallyinvasive cosmetic method from claim 68, wherein the heating element ofthe energy transfer device is constructed so that it increases itstemperature in response to energy generated by the external generationdevice.
 70. The minimally invasive cosmetic method from claim 68,wherein the external generation device allows to generate energy that istransferred to the energy transfer device, selected from the listcomprising an electromagnetic field generator and an electric currentgenerator.
 71. The minimally invasive cosmetic method from claim 68,wherein by controlling the temperature and time of the heat applicationfrom the energy transfer device, the dermis layer that is in directcontact with the energy transfer device achieves a shrinkage rate ofbetween 5-35%.
 72. The minimally invasive cosmetic method from claim 71,wherein the shrinkage rate can be achieved in one or multipleapplications.
 73. The minimally invasive cosmetic method from claim 68,wherein the technician is able to visualize and evaluate the linealshrinkage of the skin in real time in order to determine next steps ofthe treatment.
 74. The minimally invasive cosmetic method from claim 68,wherein two or more energy transfer devices are inserted into the dermislayer of the skin, and afterwards the heating and/or fluidadministration processes can be performed simultaneously on at least twoof the inserted energy transfer devices.
 75. The minimally invasivecosmetic method from claim 68, wherein the anesthetic comprises asolution having a lidocaine concentration between 0.1% to 2%.
 76. Theminimally invasive cosmetic method from claim 68, wherein the anestheticcomprises a solution having a lidocaine concentration between 0.1% to 2%that is mixed with epinephrine diluted to 1:100,000 to 1:500,000. 77.The minimally invasive cosmetic method from claim 68, wherein the methodcomprises administering additional treatment substances through the atleast one orifice in the energy transfer device.
 78. The minimallyinvasive cosmetic method from claim 77, wherein the treatment substancescomprise collagen and/or collagen inductors including but not limited tocalcium hydroxyapatite, poly-L-lactic acid, and hyaluronic acid, ananti-inflammatory, an anti-bruising substance, and other type ofsubstances that can help in the treatment and/or recovery of the treatedzone.
 79. The minimally invasive cosmetic method from claim 68, whereinthe anesthetic is mixed with the treatment fluids and administeredsimultaneously through the energy transfer device.
 80. The minimallyinvasive cosmetic method from claim 68, wherein the cooling of the skinis performed with cooling means that comprise cold air, ice, or coldcompresses.
 81. The minimally invasive cosmetic method from claim 68,wherein the cooling of the skin does not require external cooling meansbut is done naturally.
 82. The minimally invasive cosmetic method fromclaim 68, wherein the cooling means is a cooling fluid administeredthrough the device or put in direct contact with the dermis or epidermiswhile inserted in the skin, to achieve localized cooling of suchtreatment area.
 83. The minimally invasive cosmetic method from claim68, wherein the method can be applied to the face and neck, as well asto other body parts.